Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents (TEAM)

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This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.

Condition or disease

Intervention/treatment

Phase

Bipolar Disorder

Drug: Lithium carbonateDrug: ValproateDrug: Risperidone

Phase 3

Detailed Description:

Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist.

Modified Side Effects Form for Children and Adolescents [ Time Frame: Measured at Week 8 ]

The Modified Side Effects Form for Children and Adolescents includes 62 potential side effects, with measures of frequency and severity for each item. Frequencies are 0=not present, 1=1-2 days, 2=3-4 days, 3=5-7 days. Severity scores are 0=not present, 1=mild (does not interfere with functioning), 2=moderate (some interference with functioning), 3=severe (functioning is significantly impaired because of side effects). Items for cardiovascular, gastrointestinal, central nervous system, ocular, mouth and nose, genito urinary, dermatology, musculo-skeletal, and other side effects are included. For analyses, side effects that were reported at any frequency and a severity of 2 or greater were considered present.

K-SADS Mania Rating Scale [ Time Frame: Measured at Week 8 ]

The K-SADS Mania Rating Scale (KMRS) is comprised of 15 items modified from WASH-U-KSADS items. The individual items are scored on a 1-6 severity scale and then these item scores are summed to create an overall KMRS score. Guidelines for interpretation are as follows: 0-11 = no or minimal mania, 12-17 = mild mania, 18-25 = moderate mania, 26+ = marked or worse mania. The maximum possible score is 64.

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Ages Eligible for Study:

6 Years to 15 Years (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks

CGAS less than or equal to 60

Good physical health

Exclusion Criteria:

Schizophrenia or any pervasive developmental disorder

Major medical or neurological disease

History of addiction to illicit substances or alcohol or drug abuse within the last 4 weeks